Cochrane Handbook for Systematic Reviews of Interventions

Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research–based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com).
The Cochrane Handboook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.


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Contents
Preface xiii
Acknowledgements xv
The Handbook editors xvii
Major contributors xix
Part 1 COCHRANE REVIEWS 1
1 Introduction 3
Sally Green, Julian PT Higgins, Philip Alderson, Mike Clarke, Cynthia D Mulrow and Andrew D Oxman
1.1 The Cochrane Collaboration 3
1.2 Systematic reviews 6
1.3 About this Handbook 7
1.4 Contributors to the Handbook 8
1.5 Chapter information 9
1.6 References 9
2 Preparing a Cochrane review 11
Edited by Sally Green and Julian PT Higgins
2.1 Rationale for protocols 11
2.2 Format of a Co chrane review 12
2.3 Logistics of doing a review 13
2.4 Publication of Cochrane reviews in print journals and books 24
2.5 Publication of previously published reviews as Cochrane reviews 26
2.6 Declaration of interest and commercial sponsorship 26
2.7 Chapter information 29
2.8 References 29
3 Maintaining reviews: updates, amendments and feedback 31
Julian PT Higgins, Sally Green and Rob JPM Scholten
3.1 Introduction 31
3.2 Some important definitions 32
3.3 Important dates associated with Cochrane reviews 39
3.4 Considerations when updating a Cochrane review 42
3.5 ‘What’s new’ and History tables 46
3.6 Incorporating and addressing feedback in a Cochrane review 48
3.7 Chapter information 48
3.8 References 49
4 Guide to the contents of a Cochrane protocol and review 51
Edited by Julian PT Higgins and Sally Green
4.1 Introduction 52
4.2 Title and review information (or protocol information) 52
4.3 Abstract 55
4.4 Plain language summary 55
4.5 Main text 55
4.6 Tables 70
4.7 Studies and references 72
4.8 Data and analyses 74
4.9 Figures 76
4.10 Sources of support to the review 77
4.11 Feedback 77
4.12 Appendices 78
4.13 Chapter information 78
4.14 References 78
Part 2 GENERAL METHODS FOR COCHRANE REVIEWS 81
5 Defining the review question and developing criteria for including studies 83
Edited by Denise O’Connor, Sally Green and Julian PT Higgins
5.1 Questions and eligibility criteria 84
5.2 Defining types of participants: which people and populations? 85
5.3 Defining types of interventions: which comparisons to make? 86
5.4 Defining types of outcomes: which outcome measures are most important? 87
5.5 Defining types of study 90
5.6 Defining the scope of a review question (broad versus narrow) 91
5.7 Changing review questions 93
5.8 Chapter information 93
5.9 References 94
6 Searching for studies 95
Carol Lefebvre, Eric Manheimer and Julie Glanville on behalf of the Cochrane Information Retrieval Methods Group
6.1 Introduction 96
6.2 Sources to search 98
6.3 Planning the search process 118
6.4 Designing search strategies 128
6.5 Managing references 142
6.6 Documenting and reporting the search process 144
6.7 Chapter information 146
6.8 References 147
7 Selecting studies and collecting data 151
Edited by Julian PT Higgins and Jonathan J Deeks
7.1 Introduction 151
7.2 Selecting studies 152
7.3 What data to collect 156
7.4 Sources of data 163
7.5 Data collection forms 164
7.6 Extracting data from reports 167
7.7 Extracting study results and converting to the desired format 170
7.8 Managing data 182
7.9 Chapter information 183
7.10 References 183
8 Assessing risk of bias in included studies 187
Edited by Julian PT Higgins and Douglas G Altman on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group
8.1 Introduction 188
8.2 What is bias? 188
8.3 Tools for assessing quality and risk of bias 190
8.4 Introduction to sources of bias in clinical trials 193
8.5 The Cochrane Collaboration’s tool for assessing risk of bias 194
8.6 Presentation of assessments of risk of bias 202
8.7 Summary assessments of risk of bias 202
8.8 Incorporating assessments into analyses 206
8.9 Sequence generation 210
8.10 Allocation sequence concealment 214
8.11 Blinding of participants, personnel and outcome assessors 217
8.12 Incomplete outcome data 219
8.13 Selective outcome reporting 226
8.14 Other potential threats to validity 230
8.15 Chapter information 234
8.16 References 235
9 Analysing data and undertaking meta–analyses 243
Edited by Jonathan J Deeks, Julian PT Higgins and Douglas G Altman on behalf of the Cochrane Statistical Methods Gr oup
9.1 Introduction 244
9.2 Types of data and effect measures 249
9.3 Study designs and identifying the unit of analysis 260
9.4 Summarizing effects across studies 263
9.5 Heterogeneity 276
9.6 Investigating heterogeneity 282
9.7 Sensitivity analyses 289
9.8 Chapter information 292
9.9 References 293
10 Addressing reporting biases 297
Edited by Jonathan AC Sterne, Matthias Egger and David Moher on behalf of the Cochrane Bias Methods Group
10.1 Introduction 298
10.2 Types of reporting biases and the supporting evidence 299
10.3 Avoiding reporting biases 308
10.4 Detecting reporting biases 310
10.5 Chapter information 324
10.6 References 325
11 Presenting results and ‘Summary of findings’ tables 335
Holger J Schünemann, Andrew D Oxman, Julian PT Higgins, Gunn E Vist, Paul Glasziou and Gordon H Guyatt on behalf of the Cochrane Applicability and Recommendations Methods Group and the Cochrane Statistical Methods Group
11.1 Introduction 335
11.2 ‘Characteristics of included studies’ tables 336
11.3 Data and analyses 337
11.4 Figures 341
11.5 ‘Summary of findings’ tables 342
11.6 Additional tables 350
11.7 Presenting results in the text 351
11.8 Writing an abstract 352
11.9 Writing a plain language summary 355
11.10 Chapter information 356
11.11 References 357
12 Interpreting results and drawing conclusions 359
Holger J Schünemann, Andrew D Oxman, Gunn E Vist, Julian PT Higgins, Jonathan J Deeks, Paul Glasziou and Gordon H Guyatt on behalf of the Cochrane Applicability and Recommendations Methods Group
12.1 Introduction 360
12.2 Assessing the quality of a body of evidence 361
12.3 Issues in applicability 367
12.4 Interpreting results of statistical analyses 369
12.5 Interpreting results from dichotomous outcomes (including numbers needed to treat) 372
12.6 Interpreting